Competing risk and heterogeneity of treatment effect in clinical trials

Abstract It has been demonstrated that patients enrolled in clinical trials frequently have a large degree of variation in their baseline risk for the outcome of interest. Thus, some have suggested that clinical trial results should routinely be stratified by outcome risk using risk models, since th...
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Autor*in:	Kent, David M [verfasserIn] Alsheikh-Ali, Alawi Hayward, Rodney A

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2008

Schlagwörter:	Sudden Cardiac Death Relative Risk Reduction Outcome Risk Implantable Cardiac Defibrillator Multicenter Automatic Defibrillator Implantation Trial

Anmerkung:	© Kent et al; licensee BioMed Central Ltd. 2008

Übergeordnetes Werk:	Enthalten in: Trials - London : BioMed Central, 2000, 9(2008), 1 vom: 22. Mai
Übergeordnetes Werk:	volume:9 ; year:2008 ; number:1 ; day:22 ; month:05

Links:	Volltext

DOI / URN:	10.1186/1745-6215-9-30

Katalog-ID:	SPR03005060X

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spelling	10.1186/1745-6215-9-30 doi (DE-627)SPR03005060X (SPR)1745-6215-9-30-e DE-627 ger DE-627 rakwb eng Kent, David M verfasserin aut Competing risk and heterogeneity of treatment effect in clinical trials 2008 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Kent et al; licensee BioMed Central Ltd. 2008 Abstract It has been demonstrated that patients enrolled in clinical trials frequently have a large degree of variation in their baseline risk for the outcome of interest. Thus, some have suggested that clinical trial results should routinely be stratified by outcome risk using risk models, since the summary results may otherwise be misleading. However, variation in competing risk is another dimension of risk heterogeneity that may also underlie treatment effect heterogeneity. Understanding the effects of competing risk heterogeneity may be especially important for pragmatic comparative effectiveness trials, which seek to include traditionally excluded patients, such as the elderly or complex patients with multiple comorbidities. Indeed, the observed effect of an intervention is dependent on the ratio of outcome risk to competing risk, and these risks – which may or may not be correlated – may vary considerably in patients enrolled in a trial. Further, the effects of competing risk on treatment effect heterogeneity can be amplified by even a small degree of treatment related harm. Stratification of trial results along both the competing and the outcome risk dimensions may be necessary if pragmatic comparative effectiveness trials are to provide the clinically useful information their advocates intend. Sudden Cardiac Death (dpeaa)DE-He213 Relative Risk Reduction (dpeaa)DE-He213 Outcome Risk (dpeaa)DE-He213 Implantable Cardiac Defibrillator (dpeaa)DE-He213 Multicenter Automatic Defibrillator Implantation Trial (dpeaa)DE-He213 Alsheikh-Ali, Alawi aut Hayward, Rodney A aut Enthalten in Trials London : BioMed Central, 2000 9(2008), 1 vom: 22. Mai (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:9 year:2008 number:1 day:22 month:05 https://dx.doi.org/10.1186/1745-6215-9-30 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 9 2008 1 22 05
allfields_unstemmed	10.1186/1745-6215-9-30 doi (DE-627)SPR03005060X (SPR)1745-6215-9-30-e DE-627 ger DE-627 rakwb eng Kent, David M verfasserin aut Competing risk and heterogeneity of treatment effect in clinical trials 2008 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Kent et al; licensee BioMed Central Ltd. 2008 Abstract It has been demonstrated that patients enrolled in clinical trials frequently have a large degree of variation in their baseline risk for the outcome of interest. Thus, some have suggested that clinical trial results should routinely be stratified by outcome risk using risk models, since the summary results may otherwise be misleading. However, variation in competing risk is another dimension of risk heterogeneity that may also underlie treatment effect heterogeneity. Understanding the effects of competing risk heterogeneity may be especially important for pragmatic comparative effectiveness trials, which seek to include traditionally excluded patients, such as the elderly or complex patients with multiple comorbidities. Indeed, the observed effect of an intervention is dependent on the ratio of outcome risk to competing risk, and these risks – which may or may not be correlated – may vary considerably in patients enrolled in a trial. Further, the effects of competing risk on treatment effect heterogeneity can be amplified by even a small degree of treatment related harm. Stratification of trial results along both the competing and the outcome risk dimensions may be necessary if pragmatic comparative effectiveness trials are to provide the clinically useful information their advocates intend. Sudden Cardiac Death (dpeaa)DE-He213 Relative Risk Reduction (dpeaa)DE-He213 Outcome Risk (dpeaa)DE-He213 Implantable Cardiac Defibrillator (dpeaa)DE-He213 Multicenter Automatic Defibrillator Implantation Trial (dpeaa)DE-He213 Alsheikh-Ali, Alawi aut Hayward, Rodney A aut Enthalten in Trials London : BioMed Central, 2000 9(2008), 1 vom: 22. Mai (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:9 year:2008 number:1 day:22 month:05 https://dx.doi.org/10.1186/1745-6215-9-30 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 9 2008 1 22 05
allfieldsGer	10.1186/1745-6215-9-30 doi (DE-627)SPR03005060X (SPR)1745-6215-9-30-e DE-627 ger DE-627 rakwb eng Kent, David M verfasserin aut Competing risk and heterogeneity of treatment effect in clinical trials 2008 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Kent et al; licensee BioMed Central Ltd. 2008 Abstract It has been demonstrated that patients enrolled in clinical trials frequently have a large degree of variation in their baseline risk for the outcome of interest. Thus, some have suggested that clinical trial results should routinely be stratified by outcome risk using risk models, since the summary results may otherwise be misleading. However, variation in competing risk is another dimension of risk heterogeneity that may also underlie treatment effect heterogeneity. Understanding the effects of competing risk heterogeneity may be especially important for pragmatic comparative effectiveness trials, which seek to include traditionally excluded patients, such as the elderly or complex patients with multiple comorbidities. Indeed, the observed effect of an intervention is dependent on the ratio of outcome risk to competing risk, and these risks – which may or may not be correlated – may vary considerably in patients enrolled in a trial. Further, the effects of competing risk on treatment effect heterogeneity can be amplified by even a small degree of treatment related harm. Stratification of trial results along both the competing and the outcome risk dimensions may be necessary if pragmatic comparative effectiveness trials are to provide the clinically useful information their advocates intend. Sudden Cardiac Death (dpeaa)DE-He213 Relative Risk Reduction (dpeaa)DE-He213 Outcome Risk (dpeaa)DE-He213 Implantable Cardiac Defibrillator (dpeaa)DE-He213 Multicenter Automatic Defibrillator Implantation Trial (dpeaa)DE-He213 Alsheikh-Ali, Alawi aut Hayward, Rodney A aut Enthalten in Trials London : BioMed Central, 2000 9(2008), 1 vom: 22. Mai (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:9 year:2008 number:1 day:22 month:05 https://dx.doi.org/10.1186/1745-6215-9-30 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 9 2008 1 22 05
allfieldsSound	10.1186/1745-6215-9-30 doi (DE-627)SPR03005060X (SPR)1745-6215-9-30-e DE-627 ger DE-627 rakwb eng Kent, David M verfasserin aut Competing risk and heterogeneity of treatment effect in clinical trials 2008 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Kent et al; licensee BioMed Central Ltd. 2008 Abstract It has been demonstrated that patients enrolled in clinical trials frequently have a large degree of variation in their baseline risk for the outcome of interest. Thus, some have suggested that clinical trial results should routinely be stratified by outcome risk using risk models, since the summary results may otherwise be misleading. However, variation in competing risk is another dimension of risk heterogeneity that may also underlie treatment effect heterogeneity. Understanding the effects of competing risk heterogeneity may be especially important for pragmatic comparative effectiveness trials, which seek to include traditionally excluded patients, such as the elderly or complex patients with multiple comorbidities. Indeed, the observed effect of an intervention is dependent on the ratio of outcome risk to competing risk, and these risks – which may or may not be correlated – may vary considerably in patients enrolled in a trial. Further, the effects of competing risk on treatment effect heterogeneity can be amplified by even a small degree of treatment related harm. Stratification of trial results along both the competing and the outcome risk dimensions may be necessary if pragmatic comparative effectiveness trials are to provide the clinically useful information their advocates intend. Sudden Cardiac Death (dpeaa)DE-He213 Relative Risk Reduction (dpeaa)DE-He213 Outcome Risk (dpeaa)DE-He213 Implantable Cardiac Defibrillator (dpeaa)DE-He213 Multicenter Automatic Defibrillator Implantation Trial (dpeaa)DE-He213 Alsheikh-Ali, Alawi aut Hayward, Rodney A aut Enthalten in Trials London : BioMed Central, 2000 9(2008), 1 vom: 22. Mai (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:9 year:2008 number:1 day:22 month:05 https://dx.doi.org/10.1186/1745-6215-9-30 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 9 2008 1 22 05
language	English
source	Enthalten in Trials 9(2008), 1 vom: 22. Mai volume:9 year:2008 number:1 day:22 month:05
sourceStr	Enthalten in Trials 9(2008), 1 vom: 22. Mai volume:9 year:2008 number:1 day:22 month:05
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	Sudden Cardiac Death Relative Risk Reduction Outcome Risk Implantable Cardiac Defibrillator Multicenter Automatic Defibrillator Implantation Trial
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container_title	Trials
authorswithroles_txt_mv	Kent, David M @@aut@@ Alsheikh-Ali, Alawi @@aut@@ Hayward, Rodney A @@aut@@
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author	Kent, David M
spellingShingle	Kent, David M misc Sudden Cardiac Death misc Relative Risk Reduction misc Outcome Risk misc Implantable Cardiac Defibrillator misc Multicenter Automatic Defibrillator Implantation Trial Competing risk and heterogeneity of treatment effect in clinical trials
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topic_title	Competing risk and heterogeneity of treatment effect in clinical trials Sudden Cardiac Death (dpeaa)DE-He213 Relative Risk Reduction (dpeaa)DE-He213 Outcome Risk (dpeaa)DE-He213 Implantable Cardiac Defibrillator (dpeaa)DE-He213 Multicenter Automatic Defibrillator Implantation Trial (dpeaa)DE-He213
topic	misc Sudden Cardiac Death misc Relative Risk Reduction misc Outcome Risk misc Implantable Cardiac Defibrillator misc Multicenter Automatic Defibrillator Implantation Trial
topic_unstemmed	misc Sudden Cardiac Death misc Relative Risk Reduction misc Outcome Risk misc Implantable Cardiac Defibrillator misc Multicenter Automatic Defibrillator Implantation Trial
topic_browse	misc Sudden Cardiac Death misc Relative Risk Reduction misc Outcome Risk misc Implantable Cardiac Defibrillator misc Multicenter Automatic Defibrillator Implantation Trial
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title	Competing risk and heterogeneity of treatment effect in clinical trials
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title_full	Competing risk and heterogeneity of treatment effect in clinical trials
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title_sort	competing risk and heterogeneity of treatment effect in clinical trials
title_auth	Competing risk and heterogeneity of treatment effect in clinical trials
abstract	Abstract It has been demonstrated that patients enrolled in clinical trials frequently have a large degree of variation in their baseline risk for the outcome of interest. Thus, some have suggested that clinical trial results should routinely be stratified by outcome risk using risk models, since the summary results may otherwise be misleading. However, variation in competing risk is another dimension of risk heterogeneity that may also underlie treatment effect heterogeneity. Understanding the effects of competing risk heterogeneity may be especially important for pragmatic comparative effectiveness trials, which seek to include traditionally excluded patients, such as the elderly or complex patients with multiple comorbidities. Indeed, the observed effect of an intervention is dependent on the ratio of outcome risk to competing risk, and these risks – which may or may not be correlated – may vary considerably in patients enrolled in a trial. Further, the effects of competing risk on treatment effect heterogeneity can be amplified by even a small degree of treatment related harm. Stratification of trial results along both the competing and the outcome risk dimensions may be necessary if pragmatic comparative effectiveness trials are to provide the clinically useful information their advocates intend. © Kent et al; licensee BioMed Central Ltd. 2008
abstractGer	Abstract It has been demonstrated that patients enrolled in clinical trials frequently have a large degree of variation in their baseline risk for the outcome of interest. Thus, some have suggested that clinical trial results should routinely be stratified by outcome risk using risk models, since the summary results may otherwise be misleading. However, variation in competing risk is another dimension of risk heterogeneity that may also underlie treatment effect heterogeneity. Understanding the effects of competing risk heterogeneity may be especially important for pragmatic comparative effectiveness trials, which seek to include traditionally excluded patients, such as the elderly or complex patients with multiple comorbidities. Indeed, the observed effect of an intervention is dependent on the ratio of outcome risk to competing risk, and these risks – which may or may not be correlated – may vary considerably in patients enrolled in a trial. Further, the effects of competing risk on treatment effect heterogeneity can be amplified by even a small degree of treatment related harm. Stratification of trial results along both the competing and the outcome risk dimensions may be necessary if pragmatic comparative effectiveness trials are to provide the clinically useful information their advocates intend. © Kent et al; licensee BioMed Central Ltd. 2008
abstract_unstemmed	Abstract It has been demonstrated that patients enrolled in clinical trials frequently have a large degree of variation in their baseline risk for the outcome of interest. Thus, some have suggested that clinical trial results should routinely be stratified by outcome risk using risk models, since the summary results may otherwise be misleading. However, variation in competing risk is another dimension of risk heterogeneity that may also underlie treatment effect heterogeneity. Understanding the effects of competing risk heterogeneity may be especially important for pragmatic comparative effectiveness trials, which seek to include traditionally excluded patients, such as the elderly or complex patients with multiple comorbidities. Indeed, the observed effect of an intervention is dependent on the ratio of outcome risk to competing risk, and these risks – which may or may not be correlated – may vary considerably in patients enrolled in a trial. Further, the effects of competing risk on treatment effect heterogeneity can be amplified by even a small degree of treatment related harm. Stratification of trial results along both the competing and the outcome risk dimensions may be necessary if pragmatic comparative effectiveness trials are to provide the clinically useful information their advocates intend. © Kent et al; licensee BioMed Central Ltd. 2008
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title_short	Competing risk and heterogeneity of treatment effect in clinical trials
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Competing risk and heterogeneity of treatment effect in clinical trials

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